Device for sealing body cavity during introduction of fluid to or extraction of fluid from said cavity

ABSTRACT

Device for sealing an opening to a body cavity while providing for the introduction of fluid to or extraction of fluid from said cavity comprising a primary sealing member slidably mounted on a catheter type flexible tube, the latter providing means for passage of fluid to and/or from said body, and a secondary sealing member also slidably mounted on said tube. In preferred embodiments the secondary sealing member includes a porous or foamed material adherent to form an absorbent interference seal about the tube and preclude the passage of fluid which might accidentally pass along the tube from the primary sealing member. In certain embodiments segments of pressure sensitive tape are also mounted about the tube to provide means for positively attaching at least the primary sealing member to the body to which it is applied.

United States Patent [1 1 Garcia Dec. 23, 1975 [75] Inventor: Fe Garcia, Detroit, Mich.

[73] Assignee: Saul A. Rosenblum, Detroit, Mich.

a part interest [22] Filed: Sept. 12, 1973 [21] Appl. No.: 396,485

[52] US. Cl 128/245; 128/239 [51] Int. Cl. A61M 3/00 [58] Field of Search 128/245, 246, 349, 2, 241,

3,766,920 l0/l973 Greene 128/246 Primary ExaminerRichard A. Gaudet Assistant ExaminerJ. Yasko Attorney, Agent, or Firm.lerome P. Bloom [57] ABSTRACT Device for sealing an opening to a body cavity while providing for the introduction of fluid to or extraction of fluid from said cavity comprising a primary sealing member slidably mounted on a catheter type flexible tube, the latter providing means for passage of fluid to and/or from said body, and a secondary sealing member also slidably mounted on said tube. In preferred embodiments the secondary sealing member includes a porous or foamed material adherent to form an absorbent interference seal about the tube and preclude the passage of fluid which might accidentally pass along the tube from the primary sealing member. In certain embodiments segments of pressure sensitive tape are also mounted about the tube to provide means for positively attaching at least the primary sealing member to the body to which it is applied.

9 Claims, 2 Drawing Figures U.S. Patent Dec. 23, 1975 BACKGROUND OF THE INVENTION This invention relates to a device useful in maintaining a seal of an opening in a living body through which fluid is introduced to and/or extracted from a body cavity. Embodiments are particularly efficaceous in the care and treatment of colostomy patients and the invention will be described with this .in mind. It will be obvious,howeve'r, thatthe form and application of the invention embodiment is not so limited and such is not intended.

The personal and diagnostic care and treatment of colostomy patients is complicated by various factors having both physical and psychological origin. his a traumatic experience. in the first instance for a patient to have to discharge waste by way of a stomach opening. This is compounded when he finds there is no muscular control at the opening surgically created for waste discharge. The-physical result is continuing leakage. This problem is multiplied when the body cavity in the area of such opening must be filled with fluid, as required, for diagnostic x-ray s, or irrigation, or cleansing purposes. Particularly, for example, when the patient must have an enema, such as a therapeutic retention enema, or to receive a radio-opaque media, is it important there be no leakage from the body cavity.

The many methods and ,devices heretofore proposed and used to seal the surgically created'opening to the body cavity forsuch purposes as here indicated have been less than satisfactory in several respects. This has been due to the fact that the prior art devices have had one or more of the following objectionable characteristics: a

.a. Theirstructu'ral arrangement made them unwieldy to apply and use.

b. Their nature was such to produce considerable discomfortto the patient.

c. They have been costly for a one purpose use and difficult to readily clean and properly sterilize for re-use. I i

d. They have lacked proper sealing capacity.

SUMMARY OF THE INVENTION The present invention eliminates the objectionable characteristics of prior art devices of the type described. Embodiments are not only simple to use but so inexpensive to fabricate thatthey can be disposed of after only one use. Their construction is such they can be quickly applied and effectively used without discomfort to a patient.

Preferred embodiments may be provided indisposable package form to include a primary and a secondary sealing member apertured to slidably mount to a soft flexible catheter type tube. The latter should preferably have arounded apertured head through which fluid may'be moved to and from a body cavity, after a gentle insertion between the lips of an opening to such cavity. The primary sealing member is designed of rubber-like material formed in a nipple-like shape, a central opening in the head of which accommodates the passage therethrough of the catheter type tubing. The aperture in the nipple head is so dimensioned that while the nipple may be readily slid along the tubev the edges of the aperture will tend tosealingly engage the tube surface on which they bear. The secondary sealing member is designed to back the base of the primary sealing member, which base is expanded to overlap the opening to the body cavity as the head of the nipple is 5 slid between the lips thereof. The secondary sealing member includes porous or foamed material which tends to adhere to and about the tube surface on which it bears, as a precaution to preclude passage of any fluid which may inadvertently or accidentally leak past the primary sealing member. In certain applications pressure sensitive tape will also slidably mount on the catheter type tube to fix and positively secure the seal afforded by the sealing members.

A primary object of the invention is to'provide a device for sealing an opening to a cavity in a living body facilitating a quick and clean introduction of fluid to and/or extraction of fluid from said cavity.

A further object of an invention is to provide a device for effecting a controlled closure of a surgical opening in a living body facilitating the temporary application of fluid to a body cavity for diagnostic or irrigation purposes. i

Another object of the invention is'to provide a disposable device of the type described which is economical to fabricate, more efficient and satisfactory in use, adaptable to a wide variety of applications and unlikely to malfunction.

With the above and other incidental objects in view as will more fully appear in the specification, the invention intended to be protected by Letters Patent consists of the features of construction, the parts and combinations thereof, and the mode of operation as hereinafter described or illustrated in the accompanying drawings, or their equivalents.

Referring to the drawings which illustrate a preferred but not the only form of embodiment of the invention,

FIG. 1 is an exploded view of an assembly constituting a temporary seal for a surgical opening to a body cavity; and

FIG. 2 is a sectional view of the secondary seal embodied in the device of FIG. 1.

As seen in the drawings, the embodiment of the invention there illustrated includes a catheter type tube 10 the delivery end 12 of which is rounded and apertured at 14. Slidably mounted on the tube 10 are a primary sealing member 16, a secondary sealing member 18, and, between said sealing members, a retention medium 20.

The sealing member 16 has a hollow nipple-like configuration, including a bulbous elongate head portion 22 and a flaring flange-like base portion 24. The head portion 22 has a central aperture 26 whichaccommodates the passage therethrough of the head of the tube 10. The edge of aperture 26 is so dimensioned as to bear closely on and about the surface of the tube 10. The sealing member 16 may be made of a soft pliable material such as a rubber composition or its equivalent, the nature of which is to make it generally adherent to but slidable on the tube 10.

As will be obvious, when a colostomy patient, for example, requires an enema, thelips to the surgical opening to the body cavity are spread first by insertion of the apertured delivery end 12 of the tube 10. Once the end 12 is inserted in the cavity, the nipple-like sealing member 16 is slid along thetube to position its head portion 22 within the body opening to bridge and form a seal between the outer surface of tube 10 and the edge of the opening. When the member 16 is fully 3 seated to serve its sealing function, its base 24 overlaps and abuts the body surface about the opening.

In the example illustrated the retention medium 20, to the rear of the sealing member 16, is included as a generally stable, centrally apertured, sheet-like segment of material which is adhesively surfaced at each of its opposite faces. Its central aperture accommodates the passage of the tube which is thrust therethrough. As the base of the sealing element 16 is caused to abut the body surface, it may be releasably secured in place by a contact adhesion of the adjacent face of the element 20 to both the base 24 and the immediately adjacent portions of the body per se. It is preferred that each of the adhesive coated surfaces of the member 20 have a temporary cover of plastic which can be stripped as and when needs require.

The secondary sealing member 18 is comprised of an envelope 28 of impermeable plastic sheet material containing a sheet segment 30 of a foamed or spongelike material capable of accommodating and/or absorbing liquid. Both the envelope and its contents have a central aperture providing for their sliding mount on the tube 10, in an obvious manner.

The sealing member 18 may be adjusted in a sense longitudinally of the tube 10 to abut and be engaged, by contact adhesion, to the retention element 20.

Once the parts 10, 16, 18, 28 and 30 are manipulated as described, one has a secure and complete seal of the body opening to which they are applied. There is a full peripheral seal about the tube and the secondary sealing member serves to receive and catch any liquid which may inadvertently be caused to pass along the tube past the adherent edge of the opening in the head of the sealing element 16. if leakage should occur, as described, this liquid will enter the envelope 28 to be picked up by the liquid accommodating or absorbent material 30.

As indicated the apparatus is applied in a preferred example to seal the surgical opening to a body cavity provided in a colostomy patient. The seal created thereby enables a clean, quick and effective introduction of a radio opaque media as necessary for Radiographic Diagnostic purposes. Retention is insured as long as required and facilitated by the fact there is no discomfort to the patient. Once the diagnostic procedure is completed the opaque media may be siphoned off through the tube 10 without loss, spillage, or soiling.

The invention thus reduces clean-up time to a minimum and prevents soilage of clothes, discomfort and physical and emotional embarrassment to the patient.

It will be obvious from the foregoing that the invention device, as illustrated, may be applied to a great variety of similar applications where a temporary seal of a cavity containing fluid or to receive fluid is required. It will of course be obvious that it is optional as to the inclusion of the retention medium 20 as a connected element. The retention medium may in certain applications be separate from the tube 10.

From the above description it will be apparent that there is thus provided a device of the character described possessing the particular features of advantage before enumerated as desirable, but which obviously is susceptible of modification in its form, proportions, detail construction and arrangement of parts without departingfrom the principle involved or sacrificing any of its advantages.

While in order to comply with the statute the invention has been described in language more or less specific as to structural features, it is to be understood that the invention is not limited to the specific features shown, but that the means and construction herein disclosed comprise but one of several modes of putting the invention into effect and the invention is therefore claimed in any of its forms or modifications within the legitimate and valid scope of the appended claims.

Having thus described my invention, I claim:

1. Apparatus for use in delivering fluid to and/or from a body cavity while maintaining a seal thereof comprising a catheter type tube, one end of which is adapted for insertion through an opening to said cavity, a first sealing member mounting on said tube, and a second sealing member mounting on said tube in following relation to the first said member, said sealing members being adjustable in a sense longitudinally of the tube following insertion of said tube end, to seal the opening to said body cavity about said tube, the first sealing member being contoured to enter said opening to bridge and form a seal between the outer surface of said tube and the edge of the body opening, the second said sealing member having a transverse dimension greater than that of the first and serving as a back-up for the first and including in connection therewith, a moisture absorbing medium.

2. Apparatus as in claim 1 characterized by said second sealing member being arranged to trap fluid which might by-pass said first member by seeping outwardly of said body cavity along the surface of said tube.

3. Apparatus as in claim 1 characterized by said first sealing member having a nipple-like configuration and a central aperture accommodating said tube, the base of said nipple-like member being formed to overlap the edges of the opening to said cavity as the head thereof is slid in to said opening to bridge the same about said tube.

4. Apparatus as in claim 1 characterized by said second sealing member including moisture absorbent pad means peripherally surrounding said tube behind said first sealing member.

5. Apparatus as in claim 4 characterized by an impermeable envelope about said moisture absorbent pad means except in the area thereof immediately about said tube means.

6. Apparatus for use in delivering fluid to and/or from a body cavity while maintaining a seal thereof comprising a catheter type tube, one end of which is adapted for insertion through an opening to said cavity, a first sealing member mounting on said tube, and a second sealing member mounted on said tube in following relation to the first said member, said second sealing member including a moisture absorbent pad means peripherally surrounding said tube behind said first sealing member and an impermeable envelope about said moisture absorbent pad means except in the area thereof immediately about said tube, said sealing members being adjustable in a sense longitudinally of said tube to seal the opening to said body cavity about said tube, the second said sealing member serving as a backup for the first, and retention means associated with at least said first sealing member for releasably fixing the same in its sealing relation to the opening to the body cavity. I

7. Apparatus as in claim 6 characterized by said retention means being embodied inmeans slidable on said tube means. I

8. Apparatus for use in delivering fluid to and/or from a body cavity through a surgically formed body opening, including a soft flexible catheter type tube an end of which is insertable in said cavity through said opening and said tube having a relatively small uniform diameter to be substantially unlimited and unobstructed in its movement into and out of said body cavity, and a sealing member on said tube having a nipple-like portion on one end and flaring therefrom to an expanded flange-like base portion, said sealing member being made of a soft pliable material and sealingly engaging around said tube, said sealing member being slidably mounted on said tube end whereby in the use of the apparatus said tube end may be inserted a selected distance into said body cavity and said sealing member then slid along said tube toward said tube end until said nipple-like portion of said member is received in said opening and said expanded flange-like base portion seats to the body around said opening and adhesive retention means slidable on said tube inwardly of said sealing member and having a transverse dimension to exceed that of said base portion of said sealing member, said retention means being advanceable outwardly upon a seated sealing member to make adherent contact with the body around said member.

9. Apparatus according to claim 8 characterized by a resilient deformable means slidably mounted on said tube inwardly of said adhesive retention means and adjustable thereon outwardly into a backing relation to a seated assembly comprising said sealing member and said adhesive retention means. 

1. Apparatus for use in delivering fluid to and/or from a body cavity while maintaining a seal thereof comprising a catheter type tube, one end of which is adapted for insertion through an opening to said cavity, a first sealing member mounting on said tube, and a second sealing member mounting on said tube in following relation to the first said member, said sealing members being adjustable in a sense longitudinally of the tube following insertion of said tube end, to seal the opening to said body cavity about said tube, the first sealing member being contoured to enter said opening to bridge and form a seal between the outer surface of said tube and the edge of the body opening, the second said sealing member having a transverse dimension greater than that of the first and serving as a back-up for the first and including in connection therewith, a moisture absorbing medium.
 2. Apparatus as in claim 1 characterized by said second sealing member being arranged to trap fluid which might by-pass said first member by seeping outwardly of said body cavity along the surface of said tube.
 3. Apparatus as in claim 1 characterized by said first sealing member having a nipple-like configuration and a central aperture accommodating said tube, the base of said nipple-like member being formed to overlap the edges of the opening to said cavity as the head thereof is slid in to said opening to bridge the same about said tube.
 4. Apparatus as in claim 1 characterized by said second sealing member including moisture absorbent pad means peripherally surrounding said tube behind said first sealing member.
 5. Apparatus as in claim 4 characterized by an impermeable envelope about said moisture absorbent pad means except in the area thereof immediately about said tube means.
 6. Apparatus for use in delivering fluid to and/or from a body cavity while maintaining a seal thereof comprising a catheter type tube, one end of which is adapted for insertion through an opening to said cavity, a first sealing member mounting on said tube, and a second sealing member mounted on said tube in following relation to the first said member, said second sealing member including a moisture absorbent pad means peripherally surrounding said tube behind said first sealing member and an impermeable envelope about said moisture absorbent pad means except in the area thereof immediately about said tube, said sealing members being adjustable in a sense longitudinally of said tube to seal the opening to said body cavity about said tube, the second said sealing member serving as a back-up for the first, and retention means associated with at least said first sealing member for releasably fixing the same in its sealing relation to the opening to the body cavity.
 7. Apparatus as in claim 6 characterized by said retention means being embodied in means slidable on said tube means.
 8. Apparatus for use in delivering fluid to and/or from a body cavity through a surgically formed body opening, including a soft flexible catheter type tube an end of which is insertable in said cavity through said opening and said tube having a relatively small uniform diameter to be substantially unlimited and unobstructed in its movement into and out of said body cavity, and a sealing member on said tube having a nipple-like portion on one end and flaring therefrom to an expanded flange-like base portion, said sealing member being made of a soft pliable material and sealingly engaging around said tube, said sealing member being slidably mounted on said tube end whereby in the use of the apparatus said tube end may be inserted a selected distance into said body cavity and said sealing member then slid along said tube toward said tube end until said nipple-like portion of said member is received in said opening and said expanded flange-like base portion seats to the body around said opening and adhesive retention means slidable on said tube inwardly of said sealing member and having a transverse dimension to exceed that of said base portion of said sealing member, saiD retention means being advanceable outwardly upon a seated sealing member to make adherent contact with the body around said member.
 9. Apparatus according to claim 8 characterized by a resilient deformable means slidably mounted on said tube inwardly of said adhesive retention means and adjustable thereon outwardly into a backing relation to a seated assembly comprising said sealing member and said adhesive retention means. 